Type 2 DiabetesPhase 2NCT00982293
The Application of Extremely Low Level Magnetic Fields as Adjunctive Treatment for Type II Diabetes
A Phase 2 study testing Resonator device in people with Type 2 Diabetes, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields, effects blood glucose and A1c levels in people with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Resonator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Type 2 Diabetes Mellitus with a hemoglobin A1c level above 7.5%, despite management of diabetes with diet and/or medication.
- Subject currently performs routine finger stick blood sugar testing as part of his or her current diabetes disease management regimen.
- Subject is ambulatory
- Subject is on stable oral medication regimen without significant side effects for at least three (3) months (stable insulin regimen NOT permissible); willingness and ability to maintain the stable oral medication regimen throughout the course of the study. If on agents suspected of contributing to hyperglycemia(see list below), subject must have been on a stable dose of this(these) agent(s) for 6 months prior to study initiation.
- Hemoglobin A1c levels within a 0.8 % range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
- Willingness to test finger stick blood sugars according to prescribed protocol.
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- Willingness to have lab test blood draws performed according to prescribed protocol
- Willingness to maintain stable diet and activity regimen for the duration of the study.
- Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve serum blood sugar levels
- Willing and able to abstain from all medications that could affect diabetes mellitus and/or any of its associated symptoms for the duration of the study
- Adequate contraceptive measures for females subjects
- Any ethnic background
Who cannot join
- Change in medical regimen within 3 months prior to initiation of study.
- Any signs of type 1 diabetes mellitus (including any history of ketoacidosis or new requirement for insulin therapy within the 6 month period prior to study initiation).
- Active significant infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level
- Change in BMI of greater than 6 % within a 3 month period prior to study initiation
- Any planned revascularization procedure.
- Symptomatic congestive heart failure.
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- Leg or foot ulceration or open wounds
- Gangrene.
- History of intermittent claudication
- Hemodialysis
- Currently being treated for malignancy
- Currently being treated with oral or intravenous catabolic steroids
- Reported consumption of more than 14 alcoholic drinks per week.
- Pregnant, breast feeding, or planning pregnancy prior to the end of participation
- Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements
- Uncontrolled hypertension
- Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia
- Uncontrolled seizure disorder
- Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
pico-tesla Magnetic Therapies
Littleton, Colorado, 80120
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes Mellitus, Pilot Study II
The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields, effects blood glucose and A1c levels in people with Type 2 Diabetes.
Read the detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator TM, as an adjunctive therapy to oral medications results in statistically significant reductions in fasting blood glucose levels, post prandial glucose levels and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids.
- Conditions
- Type 2 Diabetes
- Being tested
- Resonator device, Resonator device - sham
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonator deviceDevice
Low level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each.
Resonator device - shamDevice
Treatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on"
| Study group | Role | What they receive |
|---|---|---|
| Active fields | Active comparator | Not described Receives: Device: Resonator device |
| Inactive device | Sham comparator | Placebo treated group, will receive the 3 times weekly for 13 weeks (39) sessions, however, the device will not be "on". Receives: Device: Resonator device - sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the improvement in Subject's hemoglobin A1c level after 13 weeks of treatment compared to baseline.
Measured: baseline, end of treatment (13 weeks) and 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2011
Why it stopped: Difficulty in Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982293
- Sponsor's protocol ID
- 09109-01
- Status last verified
- May 2011
- First submitted
- 21 Sep 2009
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes Mellitus, Pilot Study II
- ClinicalTrials.gov ID
- NCT00982293
- Acronym / sponsor ID
- 09109-01
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in Recruitment
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields, effects blood glucose and A1c levels in people with Type 2 Diabetes.
Detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator TM, as an adjunctive therapy to oral medications results in statistically significant reductions in fasting blood glucose levels, post prandial glucose levels and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active fields | Active comparator | Device: Resonator device |
| Inactive device | Sham comparator | Device: Resonator device - shamPlacebo treated group, will receive the 3 times weekly for 13 weeks (39) sessions, however, the device will not be "on". |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Current diagnosis of Type 2 Diabetes Mellitus with a hemoglobin A1c level above 7.5%, despite management of diabetes with diet and/or medication.
- Subject currently performs routine finger stick blood sugar testing as part of his or her current diabetes disease management regimen.
- Subject is ambulatory
- Subject is on stable oral medication regimen without significant side effects for at least three (3) months (stable insulin regimen NOT permissible); willingness and ability to maintain the stable oral medication regimen throughout the course of the study. If on agents suspected of contributing to hyperglycemia(see list below), subject must have been on a stable dose of this(these) agent(s) for 6 months prior to study initiation.
- Hemoglobin A1c levels within a 0.8 % range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
Key exclusion criteria (19 listed)
- Change in medical regimen within 3 months prior to initiation of study.
- Any signs of type 1 diabetes mellitus (including any history of ketoacidosis or new requirement for insulin therapy within the 6 month period prior to study initiation).
- Active significant infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level
- Change in BMI of greater than 6 % within a 3 month period prior to study initiation
- Any planned revascularization procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resonator deviceLow level electromagnetic fields for whole body immersion, 3 times weekly for 13 weeks (39) sessions of approximately 11/2 hours each. | Device | Active fields |
| Resonator device - shamTreatment, 3 times weekly for 13 weeks (39) sessions - device will not be "on" | Device | Inactive device |
Primary outcome
The primary outcome measure is the improvement in Subject's hemoglobin A1c level after 13 weeks of treatment compared to baseline.
Time frame: baseline, end of treatment (13 weeks) and 3 months post treatment
Results and safety
The study was stopped early (reason given: Difficulty in Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resonator device in people with Type 2 Diabetes, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the improvement in Subject's hemoglobin A1c level after 13 weeks of treatment compared to baseline. (time frame: baseline, end of treatment (13 weeks) and 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.